A Safety and Efficacy Study of Intravenous 131I-TM601 in Adult Patients With Malignant Melanoma

Exclusion Criteria

• •Patient May Not:
• •1. Have a serious concurrent infection or medical illness which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety. Examples of medical illnesses include, but are not limited to, the following: uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, known history of HIV, Hepatitis B or Hepatitis C infection, or psychiatric illness/social situation which would limit compliance with study requirements.
• •2. Have CNS metastases, unless, in the PI's judgment, the CNS involvement is stable and not likely to require further palliative therapy to the CNS during the course of the treatment protocol. If previous treatment has included radiotherapy, CNS disease should be stable at least 6 weeks from receipt of previous radiotherapy.
• •3. Have a prior malignancy with less than 3-year disease-free interval, except for adequately treated basal cell or squamous cell carcinoma of the skin, or in situ cancer of the cervix.
• •4. Have received radiation treatments \< 6 weeks prior to first study drug administration (Imaging Dose).
• •5. Have previously received radiation to ≥ 25% red bone marrow.
• •6. Have received any cytotoxic chemotherapy, hormonal therapy, or immunotherapy, whether conventional or investigational, \< 4 weeks prior to receiving the first study drug (Imaging Dose) administration in this study (6 weeks for mitomycin-C or nitrosoureas).
• •7. Have a history of pulmonary embolism within 1 year or deep venous thrombosis within six months of study enrollment.
• •8. Current or recent history of high-dose aspirin, warfarin, or heparin use (Aspirin \< or = 81 mg/day, low-dose warfarin \< 1 mg/day, or low-dose heparin for IV catheter patency is allowed).
• •9. Received investigational agents within 4 weeks prior to receiving the first study drug (Imaging Dose) administration in this study.
• •10. Have a history of allergic reactions attributed to compounds of similar chemical or biological composition to 131I-TM601 e.g. iodine or iodine-containing drugs.